The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title:

The Effects of Focal Vibration on Central and Peripheral Spasticity in Multiple Sclerosis Patients. A Randomized, Multicenter, Double Blinded vs Placebo Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02848898
• Other study ID #: 71/15
• Status: Not yet recruiting
• Phase: N/A
• First received: July 22, 2016
• Last updated: July 26, 2016
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2016
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethical Commitee
• Study type: Interventional

Clinical Trial Summary

This trial consists of application of little devices (named Equistasi®) generating focal vibrations to treat spasticity in neurological patients, affected by multiple sclerosis. The expected effects are on gait and postural instability.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Multiple Sclerosis affected

• Spasticity

• EDSS (Expanded Disability Status Scale) 0 - 5,5

• Patients able to sign informed consent

Exclusion Criteria:

• Age less than 18 years old and more than 65 years old

• Pacemaker

• Pregnancy

• Comorbidities as: cancer, hypertension not controlled by drugs

• concurrent therapies with antidepressant or corticosteroids

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity
• Sclerosis

Intervention

Device:
• Equistasi

Other:
• Placebo

Locations

Country	Name	City	State
Italy	Prof. Giuseppe Orefice	Naples	Campania

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Velocity	evaluation of gait velocity in m/s	one year	No
Primary	First step length	first step length in cm	one year	No
Primary	Swing phase	swing phase measured in seconds	one year	No
Primary	Stance phase	stance phase measured in seconds	one year	No
Primary	Double support time	double support time measured in seconds	one year	No
Secondary	H/M ratio	evaluation of neurophysiological modifications in treated patients vs placebo group, as ratio between H max and M max in tibial posterior nerve, in Unit	one year	No
Secondary	Berg Balance Scale	Evaluation of balance with a self administered scale, measured in Unit	one year	No
Secondary	Modified Fatigue Scale	evaluation of fatigue with a self administered scale, measured in Unit	one year	No